BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDURANT II

    MDR report key: 3863928 · Received June 10, 2014

    Report

    Report Number
    2953200-2014-01167
    Event Type
    Death
    Date Received
    June 10, 2014
    Date of Event
    May 17, 2014
    Report Date
    May 19, 2014
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCLUSION: PRE-OP RUPTURE.

    Description of Event or Problem · 1

    AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN THE PATIENT FOR THE ENDOVASCULAR TREATMENT OF A PRE-OPERATIVE RUPTURE OF THE ABDOMINAL AORTIC ANEURYSM. DURING THE INDEX PROCEDURE, DEPLOYMENT OF THE STENT GRAFT WAS UNEVENTFUL AND THE PROCEDURE WAS COMPLETED WITHOUT ENDOLEAK. PATIENT¿S BLOOD PRESSURE KEPT BETWEEN 70-80 LEVEL; THEREFORE, POST-OPERATIVE A BLOOD TRANSFUSION WAS GIVEN TO THE PATIENT. IT WAS REPORTED THAT THE PATIENT EXPIRED THE FOLLOWING DAY. THE PHYSICIAN STATED THAT THIS CASE WAS NOT RELATED TO EVAR AND THE RELEVANT DEVICES AND THE CAUSE OF DEATH WAS DUE TO RETRO PERITONEUM RUPTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340873 ENDURANT II SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V04108143

    Patients

    Seq Age Sex Outcome Treatment
    1 00073 YR Death| R